A new prescription to treat prescription drug abuse

Summary:Prescription drugs have arguably become more dangerous to addicts than street drugs. The pharmaceutical industry may have uncovered a treatment that reduces dependence by restoring the functions that opioids disrupt.

Prescription drugs have arguably become more dangerous to addicts than street drugs. The pharmaceutical industry may now have uncovered an effective treatment that reduces dependence by restoring the functions that opioids disrupt, and it presents the manufacturer with a major market opportunity for its therapy.

A recent Centers for Disease Control and Prevention (CDC) study found that over 30,000 people were killed from prescription drug abuse in 2008, which now exceeds the death toll from illegal drugs. Car accidents took just slightly more lives. The cost of painkiller abuse can exceed US$70 billion annually, the report noted. That does not include the social problems they perpetuate and addicts' lost or stalled potentials.

Clinical trials are now underway in New York to determine the efficacy of MediciNova's Ibudilast for treating dependency involving prescription drugs such as OxyContin, Percocet, and Vicodin. The drug is a powerful anti-inflammatory that is usually indicated for patients suffering from asthma and strokes. It is helpful in the treatment of addiction, because it crosses the blood brain barrier and restores normal "glial cell" activity. That has the benefit of diminishing the intense opioid cravings that can cause prescription drug abusers to relapse.

"The drug of abuse can cause physical neuronal damage that may take a significant period of time to correct," said MediciNova chief scientific officer, Dr. Kirk Johnson. "So it is expected that MN-166 (the test code for Ibudilast) would be a therapy subjects would take for a considerable period of time to successfully manage initial withdrawal and the high-risk period for relapse." That is, after the FDA approves it for sale.

MediciNova estimates that it could take five years for Ibudilast to come to market in the United States. The drug been approved in Japan for the aforementioned uses for over 15 years, and has a safety database of millions of patients, Johnson said. It would be taken at home, and a course of treatment could last between 6-18 months, or until the patient's brain has recovered and necessary lifestyle changes have been made.

The prescription trial was announced last month, and is being funded by the National Institutes for Drug Abuse (NIDA), part of the National Institutes of Health. Another trial is already underway to determine whether Ibudilast would be helpful in treating methamphetamine addiction. Alleviation of withdrawal symptoms and a reduction in relapses has been observed in animal models, Johnson noted.

If approved, MediciNova believes that it will be able to meet demands based on NIDA's assumption that 20 percent of the 350,000+ meth addicts would seek a pharmaceutical treatment every year. The number of prescription abusers is even higher, but MediciNova says that it will be able to manufacture required amounts.

MediciNova cannot comment on a price point yet, but cited Dr. Phil Skolnick, director of pharmacotherapies & medical consequences of drug abuse at NIDA stating that a $1,000/month price point for a six-month course of treatment was reasonable. The market opportunity is well above $400M per annum for meth alone.

Reckitt Benckiser currently sells over $1.2B of Suboxone, a drug used for treating opioid dependence, annually, a MediciNova spokesperson said. When asked if it was ironic that a prescription drug will be used to wean people off of other prescription drugs, Johnson demurred, noting that some drugs are safer than others.

"It is not really ironic at all; not all prescription drugs are created equal, and opioids especially are hazardous to long-term health (and potentially, if abused, short-term health as well)," he said.